| CTRI Number |
CTRI/2016/06/006987 [Registered on: 02/06/2016] Trial Registered Retrospectively |
| Last Modified On: |
13/05/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic management of decreased mouth opening due to tobacco chewing. |
|
Scientific Title of Study
|
Further Study On Ayurvedic Management Of Sarvasara wsr To Oral Submucous Fibrosis(OSMF) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
preeti patel |
| Designation |
research scholar |
| Affiliation |
IPGT AND RA, G.A.U. JAMNAGAR |
| Address |
DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U. JAMNAGAR
Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India
DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U. JAMNAGAR
Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
8141797140 |
| Fax |
|
| Email |
preetipatel346@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfManjush R |
| Designation |
H.O.D OF SHALAKYA DEPARTMENT |
| Affiliation |
IPGT AND RA, G.A.U. JAMNAGAR |
| Address |
DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U. JAMNAGAR
Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India
DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U. JAMNAGAR
Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
7600901848 |
| Fax |
|
| Email |
bhatrajma2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ProfManjush R |
| Designation |
H.O.D OF SHALAKYA DEPARTMENT |
| Affiliation |
IPGT AND RA, G.A.U. JAMNAGAR |
| Address |
DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U. JAMNAGAR
Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India
DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U. JAMNAGAR
Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
7600901848 |
| Fax |
|
| Email |
bhatrajma2008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University
Jamnagar – 361008 |
|
|
Primary Sponsor
|
| Name |
IPGT AND RA |
| Address |
INSTITUTE FOR POST GRADUATION TEACHING AND
RESEARCH IN AYURVEDA OPP. CITY B POLICE STATION PN
MARG JAMNAGAR |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Preeti Patel |
Department of shalakya,I.P.G.T & R.A,Jamnagar |
Room no 434
Institute for Post
Graduate Teaching and
Research in Ayurveda
Gujarat Ayurved
University Jamnagar –
361008 Jamnagar
Jamnagar GUJARAT
Jamnagar
GUJARAT |
8141797140
preetipatel346@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar – 361008 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
IN ABILITY TO OPEN MOUTH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
group A |
group a First of all Erandbhristha Haritaki will be given for Kosthasuddhi for 3 days followed by Shadabindu Taila Shodhan Nasya for 5 days. Madhu-pippalyadi Yoga for Pratisarana. Nishadi Taila for Kavala. RasayanaYoga orally for 45 days |
| Comparator Agent |
Group B |
M V NERVE OD
1 capsule od |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The patients having clinical signs and symptoms of OSMF-blanching
and stiffness of oral mucosa, trismus, burning sensation in mouth,
intolerance to eating hot and spicy foods, repeated vesicular eruption
and ulceration on the bucal mucosa, palate, and pillars; reduced
mobility of soft palate and tongue, loss of gustatory sensation etc.
Interincisal distance between 15mm-40mm. |
|
| ExclusionCriteria |
| Details |
Extensive fibrosis of all the oral mucosa, severe trismus with an
interincisal distance of less than 15mm.
Disease is most advanced with premalignant and malignant
changes.
Generalized fibromatosis.
Oral manifestation of scleroderma.
Oral lichen planus.
Pale oral mucosa of anemia.
Chronic debilitating conditions like DM, HT, HIV etc.
Patients not willing to give up habits of gutkha, pan-masala, mawa,
tobacco, betel quid or betel nut chewing. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in interincisal distance |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief from symptoms of oral submucous fibrosis |
45 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
04/03/2016 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Oral Submucous Fibrosis (OSMF) is a chronic debilitating disease of the oral cavity resulting from habits like smoking, alcoholism, mawa, pan-masala, gutkha, tobacco, betel nut and betel quid chewing. In Group A First of all Erandbhristha Haritaki will be given for Kosthasuddhi for 3 days followed by Shadabindu Taila Shodhan Nasya for 5 days. After that following treatment will be given simultaneously for 45 days. · Madhu-pippalyadi Yoga for Pratisarana. · Nishadi Taila for Kavala. RasayanaYoga orally In Group B Physiotherapy and antioxidants M V NERVE OD |